Relaxation-Response-based Mental Health Promotion - Open and Calm 2013

NCT ID: NCT02140307

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of the study is to investigate health-promoting and stress-reducing psychological, physiological and hormonal effects of a 9-week meditation-based course in personal health and to examine potential baseline factors for any such effects. Thus, the investigators will investigate the course format (individual course or group-based course) as a potential factor the course outcome, and also individual background factors such as demographics and genetic variations.

Conditions

Stress Psychological; Stress Physiological; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Meditation training, group format

The course Relaxation Response-based Mental Health Promotion (publicly referred to as "Open and Calm") is given in group format.

The intervention entails 9 courses (1 per week of 2.5 hrs), a course book (120 pages), audio support (6 guided meditative practices), access to a webpage with additional information, and the possibility of two personal sessions with the intervention instructor (a certified psychologist).

Group Type: EXPERIMENTAL

Relaxation Response-based Mental Health Promotion (RR-MHP)

Intervention Type: BEHAVIORAL

The Open and Calm intervention is based on a standardized 9-week program. Week 1 uses a simple mantra-based meditation. Week 2 and 5 uses focus on the body. Week 3 and 6 uses focus on thoughts and emotions. Week 4 and 7 uses focus on social relationships. Weeks 8 and 9 were entitled "The focus you feel like", where participants chose their own focus (e.g. two weeks of bodily focus if that was most relevant for a person, while another might chose 1 week focusing on emotions and another focusing on a social relationship).

Meditation training, individual format

The course Relaxation Response-based Mental Health Promotion ("Open and Calm") is given by the same instructor as for group formats using precisely the same material and methods, but in about 6-9 (as to each persons' individual needs and preferences) face-to-face meetings.

Group Type: ACTIVE_COMPARATOR

Relaxation Response-based Mental Health Promotion (RR-MHP)

Intervention Type: BEHAVIORAL

The Open and Calm intervention is based on a standardized 9-week program. Week 1 uses a simple mantra-based meditation. Week 2 and 5 uses focus on the body. Week 3 and 6 uses focus on thoughts and emotions. Week 4 and 7 uses focus on social relationships. Weeks 8 and 9 were entitled "The focus you feel like", where participants chose their own focus (e.g. two weeks of bodily focus if that was most relevant for a person, while another might chose 1 week focusing on emotions and another focusing on a social relationship).

Wait-list control

This arm is an inactive wait-list control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Relaxation Response-based Mental Health Promotion (RR-MHP)

The Open and Calm intervention is based on a standardized 9-week program. Week 1 uses a simple mantra-based meditation. Week 2 and 5 uses focus on the body. Week 3 and 6 uses focus on thoughts and emotions. Week 4 and 7 uses focus on social relationships. Weeks 8 and 9 were entitled "The focus you feel like", where participants chose their own focus (e.g. two weeks of bodily focus if that was most relevant for a person, while another might chose 1 week focusing on emotions and another focusing on a social relationship).

Intervention Type: BEHAVIORAL

Other Intervention Names

Open and Calm; Open & Calm; RR-MHP; Relaxation Response Resiliency Program; 3RP

Eligibility Criteria

Inclusion Criteria

• Experience of stress, defined as a Cohen's perceived stress scale score > 12.
• Speaks and reads Danish fluently.
• Ability to use the internet to complete questionnaires.
• Participation in face-to-face study information meeting.
• Signed agreement to the study conditions and informed consent form

Exclusion Criteria

• Other current treatment (psychological, medical or other) for stress, depression, anxiety, phobias, traumas or other psychological problems.
• Other current treatment for bodily illnesses, such as pain, migraine, cancer.
• More than one diagnose with psychiatric disease (e.g. anxiety, depression) within the past 3 years.
• Body-Mass Index > 30.
• Major Depression Inventory score > 25 at inclusion interview.
• Physical handicaps affecting life stress or quality of life chronically.
• Drug use (> 50 times hash during the past two years; max 20 times harder drugs, max 2 times per month since the 18th birthday on average; no periods > 3 years where the use of drugs exceeded two times per month).
• Alcohol use > 21 drinks/week for men, and > 14 drinks/week for women and AUDIT-scores (a scale of alcohol-related problems) >20.
• Serious head trauma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordea-Fonden, Denmark

UNKNOWN

Sponsor Role: collaborator

Steen G Hasselbalch

OTHER

Sponsor Role: lead

Responsible Party

Steen G Hasselbalch

Professor, dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian G Jensen, MSc.

Role: PRINCIPAL_INVESTIGATOR

Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)

Steen G Hasselbalch, Professor

Role: STUDY_DIRECTOR

Memory Clinic, Copenhagen University Hospital (Rigshospitalet)

Gitte M Knudsen, Professor

Role: STUDY_CHAIR

Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)

Locations

Neurobiology Research Unit, dep. 9201, Copenhagen University Hospital (Rigshospitalet)

Copenhagen OE, , Denmark

Countries

Denmark

References

Jensen CG, Lansner J, Petersen A, Vangkilde SA, Ringkobing SP, Frokjaer VG, Adamsen D, Knudsen GM, Denninger JW, Hasselbalch SG. Open and Calm--a randomized controlled trial evaluating a public stress reduction program in Denmark. BMC Public Health. 2015 Dec 16;15:1245. doi: 10.1186/s12889-015-2588-2.

Reference Type: DERIVED

PMID: 26673225 (View on PubMed)

Related Links

http://www.nru.dk

Homepage of the central investigating research unit

Other Identifiers

RR-MHP-OC13

Identifier Type: -

Identifier Source: org_study_id